Its Time to Talk About Chemical Characterisation

A team of nine authors from the Center for Devices and Radiological Health, U.S. Food and Drug Administration have published : Chemical Characterization and Non-targeted Analysis of Medical Device Extracts: A Review of Current Approaches, Gaps, and Emerging Practices.  

The review is a detailed examination of the current state of the art gleaned from 252 references. It also references the use of ISO 10993-18 in the evaluation of the biological safety of devices and the use of chemical analysis when sufficient information is not available form material suppliers for this evaluation. Also discussed is the replacement of biological testing for systemic toxicity, geneotoxicity, carcinogenicity, and reproductive/developmental toxicity by extractable testing, chemical characterisation and toxicity risk assessment.

MET has proposed a system of relating the intensity of chemical analysis to the ISO 10993-1 biocompatibility matrix. 

This system uses levels 1 to 3 of increasing extraction intensity and analytical investigation for skin contact at level one to permanent implant at level three. Levels four and five are applied to pharmaceutical containers and single use production systems. That is extractables and leachables, and BPOG. 

Do contact us to discuss how the levels might apply to your device or pharmaceutical system. We always take a non-targeted approach and we always work on a fixed price basis.